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NCT00452426 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
A Phase 3 study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
NCT00452426: Completed Phase 3 study, sponsored by Ethicon Endo-Surgery.
NCT00452426 is a Phase 3 study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 1,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00452426, a Phase 3 study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
Study Summary
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.
Primary Outcome
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds\*percent.
Interventions
- DEVICE Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
- OTHER benzodiazepines and opioid sedation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
What the finished NCT00452426 record still lists
NCT00452426 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 2 interventions - of which Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) is the first listed.
NCT00452426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00452426 about?
NCT00452426 is a clinical study titled "Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy". Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to sa...
What is the current status of trial NCT00452426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2007-03. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00452426?
The interventions under investigation include: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) (DEVICE), benzodiazepines and opioid sedation (OTHER).
Who is sponsoring clinical trial NCT00452426?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00452426's enrollment target sits among peer trials
1,000 296th of 2000 higher than 1,689 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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